South Florida Dialysis Center Corp

“Dialysis Emergency Medical System Assistance CFR(s): §494.62(b)(8) Condition for Coverage: [(b) Policies and procedures. The dialysis facility must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. At a minimum, the policies and procedures must address the following:] (8) How emergency medical system assistance can be obtained when needed. This Standard is not met as evidenced by: 29151 Based on policy review and interview, it was determined, the facility Emergency Preparedness Plan, failed to delineate the responsibilities between the dialysis staff and the nursing home staff during a patient care emergency. The findings included: Review of the facility Emergency Preparedness Plan, not dated, revealed 911 would be activated if a life threatening medical emergency arises during dialysis. The staff would stop dialysis treatment as applicable during a medical emergency. Interview with the two dialysis technicians on duty on 07/09/24 at 9:13 AM revealed if they have a medical emergency, they will call the nursing home nurse and the nurse will determine if there is a need to call 911. The dialysis staff does not have emergency equipment on hand, the nursing home has it. Interview with The Director of Nursing from the dialysis facility conducted on 07/09/24 at 11:38 AM revealed the dialysis staff relies on the nursing staff from the nursing home, in case of an emergency. The nursing home would do the evaluation and call 911 if needed. The dialysis staff can manage fluid replacement, but they will call for help as needed. Interview with The Nursing Home Nurse Practitioner on 07/08/24 at 12:55 PM revealed she communicates with the nephrology team as needed, the dialysis team handles their medical emergencies, of course the nursing home team would assist if needed, but the dialysis staff provide overall management if the resident has a dialysis related medical emergency during treatment. Interview with The Administrator of the nursing home conducted on 07/08/24 at 3:04 PM revealed the facility is not affiliated with the dialysis unit onsite. The nursing home provides the space for the dialysis treatments. Upon request a copy of the agreement between the facilities was provided. Agreement between the nursing home and the dialysis facility signed 10/31/23 documents the following: A. OBLIGATIONS OF NURSING FACILITY I . Provision of ESRD resident information. For each ESRD resident who elects to receive home Hemodialysis services from Provider, who is an appropriate candidate for such services as determined by Resident attending physician and documented in the resident medical record, SNF shall provide the following information to Provider: a. ESRD Resident’s name, address, date of birth, and Social Security Number b. Name, address, and telephone number of the ESRD Resident’s next of kin or legal representative. c. ESRD resident’s third-party payor data. d. Appropriate medical record e. Treatment presently being provided to the ESRD resident, including meds. f, Any advance directive executed by the ESRD resident. g. All treatment plans, orders, prescriptions by attending by the attending physician, 2. The SNF will provide Provider with centralized space sufficient and approved by Provider as sufficient, for the administration of the services including space for water purification, and dialysis equipment and any supplies, which may be necessary to complete the services hereunder. 3. The SNF agrees to provide biohazard waste services to the Provider. 4. The SNF agrees to provide all the necessary non dialysis related supplies, equipment, utilities, including electricity, air conditioning/ heating and water for the provision of dialysis at the SNF. No remuneration is provided for these supplies. 5. The SNF agrees to provide daily cleaning of the provided space including trash removal and cleaning of floors, as it would had Provider not provided and services at the Facility. B. OBLIGATIONS OF PROVIDER provider will perform dialysis treatments for interested SNF residents upon the request and written orders of the patient’s licensed Nephrologist. All’ requested treatments will be delivered by trained and experienced personnel, under the full-time supervision of a licensed and registered nurse provided by the Provider. Coverage will be available twenty-four (24) hours a day, seven (7) days a week, a roster will be posted with all staff members. Provider will use a Method I billing, for provisions of supplies and equipment in providing home dialysis treatments, and assumes responsibility for all aspects of care and compliance including but not limited to: I . Multidisciplinary and individualized patient care plans 2. Pre and Post treatment “hand off” communications with SNF staff 3, Pre and Post weights 4. Review MD orders prior to each treatment 5. Assessment and monitor fluid status and vital signs. 6. Manage dialysis equipment and reverse osmosis maintenance and repairs. 7. Manage complications 8. Evaluate progress of patients toward established goals 9. Monitoring nutritional needs by a Registered Dietitian 10. Monitoring support services and emotional needs by a Renal Social Worker 11. Educate and train staff to reduce the risk of infection. 12. Perform monthly water and dialysate microbiology cultures and semiannual AAMI studies 13. Monthly Quality Improvement reports 14. Maintain accessible, properly documented, and organized medical records for easy retrieval of information 15. Assure responsibility of quality care and services, while adhering to policy and procedure manual 16. Maintain personnel files and documentation in accordance with SNF standards 17. Provide Mircera and bill third party payors 18. Assume and treat all dialysis related emergencies 19. Maintain the proper function and operation of any equipment used for the services 20. At no time shall SNF be responsible for the equipment, the repair, maintenance, or replacement thereof, it being understood by Provider that its administration of dialysis, at any stage, shall demonstrate that Facility provided Provider with everything needed for Provider to safely perform dialysis 21. Provider shall document the chart indicating, in detail, the administration of dialysis noting any items of concern and consideration therein as well as Provider also being responsible to proactively communicate and follow up care or concerns with the SNF. Provider shall also communicate status of dialysis and an concerns with the patient and/or patient’s responsible party whenever possible” 22. Provider shall immediately alert SNF of any emergency not related to dialysis services”

“IC-DISINFECT SURFACES/EQUIP/WRITTEN PROTOCOL CFR(s): 494.30(a)(4)(ii) [The facility must demonstrate that it follows standard infection control precautions by implementing- (4) And maintaining procedures, in accordance with applicable State and local laws and accepted public health procedures, for the-] (ii) Cleaning and disinfection of contaminated surfaces, medical devices, and equipment. This Standard is not met as evidenced by: 29151 Based on observation and staff interview, it was determined, the clinical staff failed to follow standard infection control precautions as evidenced by failure to thoroughly disinfect the dialysis station and the Myron meter after each use. The findings included: Observation of care conducted on 07/09/24 at 10:08 AM revealed Staff B, a Patient Care Technician, disinfecting Station #1. Staff B disinfected the dialysis chair, did not open the sides or recline the chair to ensure all surfaces were clean. In addition, the staff did not disinfect the two jugs sitting at the bottom of the dialysis machine. Observation of care revealed Staff B, a Patient Care Technician, using the Myron meter on 07/09/24 at 11:12 AM (Station #2). The staff took the meter to the station, poured the water specimen, swirled the plunger once, read the results, then took the meter to the sink and rinsed with tap water. Staff B placed the meter back on top of the shelf. and failed to disinfect the meter. Interview with Staff A and The Director of Nursing on 07/09/24 at 1:22 PM revealed the dialysis chairs do recline and the sides open so they can be cleaned. The staff was also asked regarding the use of the Myron meter, and acknowledged the meter should be disinfected if taken to the station.”

“IC-ASEPTIC TECHNIQUES FOR IV MEDS CFR(s): 494.30(b)(2) [The facility must-] (2) Ensure that clinical staff demonstrate compliance with current aseptic techniques when dispensing and administering intravenous medications from vials and ampules; and This Standard is not met as evidenced by: 29151 Based on observation and staff interview, it was determined, the clinical staff failed to ensure the standards of practice regarding properly labeling multi-dose vials and aseptic technique when drawing intravenous medications were implemented during 1 of 1 observation of medication administration. The findings included: Observation of the medication cabinet revealed one vial of Heparin, 30,000 units, opened, halfway filled with no open date. There is a box of Micera 50 micrograms stored inside the specimen fridge. Observation of Heparin administration on 07/09/24 at 9:52 AM revealed Staff A, a Patient Care Technician, preparing medication for Patient #2. The staff removed the syringes and Heparin vial from the cabinet and donned clean gloves. The staff inserted the syringe/needle into the heparin vial, drew the medication and then continued to insert the second syringe/needle for the second dose. Staff A failed to disinfect the rubber top with alcohol prior to inserting the needles and drawing the medications and failed to perform hand hygiene prior to preparing the medication. Interview with Staff A and The Director of Nursing on 07/09/24 at 1:22 PM confirmed the Heparin vial was not dated, The DON stated she just did it and acknowledged the medications should not be stored in the fridge with specimens. Staff A acknowledged the findings.”

“IC-STAFF EDUCATION-CATHETERS/CATHETER CARE CFR(s): 494.30(a)(2) Recommendations for Placement of Intravascular Catheters in Adults and Children I. Health care worker education and training A. Educate health-care workers regarding the ... appropriate infection control measures to prevent intravascular catheter-related infections. B. Assess knowledge of and adherence to guidelines periodically for all persons who manage intravascular catheters. II. Surveillance A. Monitor the catheter sites visually of individual patients. If patients have tenderness at the insertion site, fever without obvious source, or other manifestations suggesting local or BSI [blood stream infection], the dressing should be removed to allow thorough examination of the site. Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients. VI. Catheter and catheter-site care B. Antibiotic lock solutions: Do not routinely use antibiotic lock solutions to prevent CRBSI [catheter related blood stream infections]. This Standard is not met as evidenced by: 29151 Based on observation, policy review and interview, it was determined, the clinical staff failed to implement aseptic technique when providing catheter care during 1 of 1 observation of care affecting Patients #5. The findings included: Observation of initiation of treatment conducted on 07/09/24 at 12:16 PM revealed Staff A performing catheter care for Patient #5. Staff A, a Patient Care Technician, was observed donning clean gloves (no hand hygiene), placed a barrier under the catheter site, removed the dirty dressing, changed gloves and proceeded to clean the site. Staff A failed to perform hand hygiene prior to donning gloves and failed to wash hands after removing the dirty gloves and cleansing the site. Interview with Staff A and The Director of Nursing on 07/09/24 at 1:22 PM confirmed the findings.”

“CARBON ADSORP-MONITOR, TEST FREQUENCY CFR(s): 494.40(a) 6.2.5 Carbon adsorption: monitoring, testing freq Testing for free chlorine, chloramine, or total chlorine should be performed at the beginning of each treatment day prior to patients initiating treatment and again prior to the beginning of each patient shift. If there are no set patient shifts, testing should be performed approximately every 4 hours. Results of monitoring of free chlorine, chloramine, or total chlorine should be recorded in a log sheet. Testing for free chlorine, chloramine, or total chlorine can be accomplished using the N.N-diethyl-p-phenylene-diamine (DPD) based test kits or dip-and-read test strips. On-line monitors can be used to measure chloramine concentrations. Whichever test system is used, it must have sufficient sensitivity and specificity to resolve the maximum levels described in [AAMI] 4.1.1 (Table 1) [which is a maximum level of 0.1 mg/L]. Samples should be drawn when the system has been operating for at least 15 minutes. The analysis should be performed on-site, since chloramine levels will decrease if the sample is not assayed promptly. This Standard is not met as evidenced by: 29151 Based on administrative record review and staff interview, it was determined, the facility failed to ensure the results of monitoring of free chlorine, chloramine, or total chlorine is recorded in a log sheet and reflects testing for free chlorine, chloramine, or total chlorine is performed at the beginning of each treatment day prior to patients initiating treatment and again prior to the beginning of each patient shift. The findings included Review of the facility’s water logs conducted on 07/09/24 revealed the staff did not perform the chlorine test prior to the beginning of each shift or every 4 hours from 06/27/24 through 07/09/24 (five treatment days). The facility provides dialysis treatments every Tuesday, Thursday and Saturday. Interview with Staff A, The Patient Care Technician, who completes the water testing, on 07/09/24 at 9:20 AM, confirmed the logs have not been completed since 06/27/24, and stated he does all the required testing daily and was unable to provide a reason why the testing was not documented.”

“PE-BUILDING-CONSTRUCT/MAINTAIN FOR SAFETY CFR(s): 494.60(a) The building in which dialysis services are furnished must be constructed and maintained to ensure the safety of the patients, the staff and the public. This Standard is not met as evidenced by: 29151 Based on observation and staff interview, it was determined, the facility failed to ensure the emergency call light system was operational in the dialysis unit. The findings included: Observation of the dialysis unit conducted on 07/09/24 at 9:05 AM revealed two wall panels to activate the emergency call light system. The panel on the back wall did not have a pull call light device attached. The Risk Manager from the nursing facility instructed the surveyor to use the second panel behind one of the dialysis machines, which had a pull cord. The pull cord was activated multiple times by the nursing home risk manager and the light did not sound or light up above the dialysis unit door. Interview with the Director of Nursing (DON) of the dialysis unit conducted on 07/09/24 at 11:38 AM revealed the facility relies on the nursing staff from the nursing home, in case of an emergency. The DON was made aware the emergency call light was not operational for the staff to summon for help and stated the nursing home facility is responsible for the emergency call light.”

“PE-EQUIPMENT MAINTENANCE-MANUFACTURER’S DFU CFR(s): 494.60(b) The dialysis facility must implement and maintain a program to ensure that all equipment (including emergency equipment, dialysis machines and equipment, and the water treatment system) are maintained and operated in accordance with the manufacturer’s recommendations. This Standard is not met as evidenced by: 29151 Based on observation, interview and manufacturer’s documentation, it was determined, the facility staff failed to follow established manufacturer’s recommendations for use of the Myron meter when checking conductivity. The findings included: Observation of care revealed Staff B, a Patient Care Technician, using the Myron meter on 07/09/24 at 10:28 AM (Station #1). The staff took the meter to the station, poured the water specimen, swirled the plunger once, read the results and then took the meter to the sink and rinsed it with tap water. Staff B placed the meter back on top of the shelf. Staff B failed to follow the manufacturer’s recommendation for use. Observation of care revealed Staff B, a Patient Care Technician, using the Myron meter on 07/09/24 at 11:12 AM (Station #2). The staff took the meter to the station, poured the water specimen, swirled the plunger once, read the results, then took the meter to the sink and rinsed with tap water. Staff B placed the meter back on top of the shelf. Staff B failed to follow the manufacturer’s recommendation for use. Interview with Staff A on 07/09/24 at 1:22 PM revealed the staff was asked regarding the use of the Myron meter, and acknowledged there is no RO (Reverse Osmosis) pure water to rinse the meter and that the meter should be disinfected if taken to the station. The staff was made aware of the observations and acknowledged the proper procedures. Myron Meter Operating Instructions documents Rinse the cell cup three times with the sample you want to test. (For very hot or very cold samples see temperature compensation below.) and rinse the cell cup with pure water immediately after use. This will prevent the build-up of unwanted deposits and possible contamination of the next sample.”

“PA-F/U REASSESSMENT-WITHIN 3 MO OF INITIAL CFR(s): 494.80(b)(2) A follow up comprehensive reassessment must occur within 3 months after the completion of the initial assessment to provide information to adjust the patient’s plan of care specified in §494.90. This Standard is not met as evidenced by: 29151 Based on record review and interview, it was determined, the Interdisciplinary Team (IDT) failed to ensure comprehensive assessments were completed at the 90-day interval for 1 of 1 sample patients (Patient #5). The findings included: Clinical record review conducted on 07/09/23 revealed Patient #5 was admitted to the facility for dialysis treatment on 12/16/23. The record documents the interdisciplinary team completed the initial comprehensive assessment and plan of care on 01/31/24. Review of the record failed to provide evidence that the comprehensive interdisciplinary ninety-day assessment has been completed as of 07/09/24 for all disciplines. Interview with the Social Worker Assistant conducted on 04/07/24 at 12:45 PM revealed the social worker completes an initial assessment and then they communicate with the nursing home social worker for any issues that need her intervention. The social worker does not complete quarterly notes or assessments for the dialysis patients. Interview with the Director of Nursing conducted on 07/09/24 at 12:58 PM confirmed after review of the clinical record, the entire interdisciplinary team has not completed the ninety-day comprehensive assessment for Patient #5.”

“POC-COMPLETED/SIGNED BY IDT & PT CFR(s): 494.90(b)(1) The patient’s plan of care must- (i) Be completed by the interdisciplinary team, including the patient if the patient desires; and (ii) Be signed by the team members, including the patient or the patient’s designee; or, if the patient chooses not to sign the plan of care, this choice must be documented on the plan of care, along with the reason the signature was not provided. This Standard is not met as evidenced by: 29151 Based on policy review, clinical record review and interview, it was determined, the interdisciplinary team failed to ensure the patient plan of care was signed by the patient acknowledging the problems, goals and interventions put in place. The failure affected 1 of 1 sampled patients (Patient #5). The findings included: Clinical record review conducted on 07/09/23 revealed Patient #5 was admitted to the facility for dialysis treatment on 12/16/23. The record documents the interdisciplinary team completed the comprehensive plan of care on 01/31/24. The record failed to provide evidence Patient #1 participated and signed acknowledgement of the plan of care or refused to sign the care plan. Interview with the Director of Nursing (DON) conducted on 07/09/24 at 12:58 PM revealed the facility holds care plan meetings at the office for all twelve nursing homes and outpatient clinics. The physician, nurse practitioner, social worker and director of nursing participates. The DON was asked if patients participate, and replied if they want to, they can. The DON was asked if they are invited and do they sign participation or acknowledgement of their plan of care and stated the plans are sent to them if requested, the patients have a care plan meeting at the nursing home and verified the dialysis staff does not participate in the nursing facility care plan meetings.”

“PQ-PCT-STATE REQUIREMENTS & HS DIPLOMA CFR(s): 494.140(e)(1),(2) Patient care dialysis technicians must- (1) Meet all applicable State requirements for education, training, credentialing, competency, standards of practice, certification, and licensure in the State in which he or she is employed as a dialysis technician; and (2) Have a high school diploma or equivalency; This Standard is not met as evidenced by: 29151 Based on administrative record review and staff interview, it was determined, the facility failed to provide evidence that all staff, patient care technicians had current demonstrated competencies necessary to perform the specific duties of their positions to serve the comprehensive needs of the dialysis patients for 2 of 2 staff reviewed. The findings included: Review of the personnel files for the two patient care technicians on duty (Staff A and B) on 07/09/24 was not completed as the facility holds personnel records offsite. Interview with the Director of Nursing conducted on 07/09/24 at 2:30 PM revealed she has reached out to the main office for the records. The DON was instructed to provide the staff competencies by end of business day on 07/10/24. On 07/11/24, the DON provided partial evidence, water treatment competencies for the selected staff. There is no evidence of other staff qualifications to care for dialysis patients including certifications, clinical competencies and emergency preparedness.”

“MD RESP-ENSURE ALL ADHERE TO P&P CFR(s): 494.150(c)(2)(i) The medical director must- (2) Ensure that- (i) All policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility, including attending physicians and nonphysician providers; This Standard is not met as evidenced by: 29151 Based on record review and interview, it was determined, the Medical Director and facility staff failed to ensure the initial nursing assessments had all required elements, including a fall risk assessment. This failure affected 1 of 1 newly admitted in center patients (Patient #1). The findings included: Clinical record review conducted on 07/09/24 revealed Patient #1 was admitted to the facility on 05/19/24. The facility Initial Nurse Assessments, Treatment Flowsheets and Progress Notes failed to document Fall Risk assessments. Interview with The Director of Nursing (DON) on 07/09/24 at 11 AM revealed the DON reviewed the electronic record and stated the facility does not complete a fall risk assessment; the nursing home would do that. The DON was asked if the dialysis staff documents that the fall risk assessment from the nursing facility was completed and reviewed and replied “no”, the patients will have a fall risk band if they are at risk.”